EP1713408B1 - Systeme für die wirbelsäulen-chirurgie - Google Patents
Systeme für die wirbelsäulen-chirurgie Download PDFInfo
- Publication number
- EP1713408B1 EP1713408B1 EP05713229A EP05713229A EP1713408B1 EP 1713408 B1 EP1713408 B1 EP 1713408B1 EP 05713229 A EP05713229 A EP 05713229A EP 05713229 A EP05713229 A EP 05713229A EP 1713408 B1 EP1713408 B1 EP 1713408B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- distractor
- implant
- paddle
- shaft
- inserter
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
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Images
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00131—Tantalum or Ta-based alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00359—Bone or bony tissue
Definitions
- the present invention relates to surgical instruments, and in particular to methods and devices for implanting spinal prostheses.
- a surgical instrument system includes a distractor having a shaft, a paddle located at the distal end of the shaft, and a filler bar shaped to removably engage the shaft and paddle of the distractor.
- the filler bar When the filler bar is engaged to the distractor, the filler bar provides rigidity and torque strength so that the distractor can be inserted between adjacent vertebrae in a first orientation and rotated to distract adjacent vertebrae.
- a distractor that maintains the empty space between adjacent vertebrae following a discectomy, and that can removably mate with other surgical instruments, such as, for example, a filler bar, an implanting tool, or a funnel.
- a distractor is disclosed having various features to assist in implanting a spinal prosthesis, such as, for example, an angled distal end and/or an expandable paddle.
- an articulating inserter is disclosed.
- various implants and funnels are also disclosed herein.
- FIGS. 1 to 8 illustrate a distractor assembly system and method for inserting a spinal prosthesis.
- FIG. 1 illustrates one embodiment of a distractor assembly 10 disclosed herein having a distractor or guide arm 12, a guide filler bar 26, and a modular handle 16. While the distractor 12 can have a variety of configurations that enable it to maintain the space between adjacent vertebrae following a discectomy, as shown in FIG. 2 , the distractor 12 has proximal and distal ends 12a, 12b with an elongate shaft 14 extending therebetween. Attached to the proximal end 12a of the distractor 12 is a handle 16 (or a portion thereof) for gripping by the surgeon.
- the handle 16 can be either fixedly or removably attached, in an exemplary embodiment, the handle 16 is removably attached to the shaft 14 by any means known in the art, such as, for example, a screw or a spring plunger, so that the surgeon can remove it to achieve increased visibility to the surgical site.
- an elongate shaft 14 Extending distally from the handle 16 is an elongate shaft 14. While the shaft 14 can have a variety of sizes, it should have a diameter that, upon insertion into the intervertebral space, allows sufficient space for the insertion of other surgical tools, such as a filler bar or an inserter for example, as well as an implant. Additionally, the shaft 14 can have a variety of shapes, such as circular, ovular, rectangular or square. As shown, the shaft 14 is rectangular and generally flat.
- the shaft 14 can also have a variety of configurations that allow for mating with another surgical instrument, such as, for example, a filler bar, an inserter, a funnel, or any other instrument used in the implanting of a spinal prosthesis.
- the shaft 14 can have a guide feature 18 such as a tooth or groove that can mate with a corresponding guide feature on another surgical instrument.
- the guide feature 18 can be formed either throughout the entire length of the shaft 14 or on a partial length thereof.
- the guide feature 18 can also have a variety of configurations depending upon the mating features of the corresponding surgical instrument.
- the guide feature 18 can be protrude from the shaft 12, or, alternatively, the guide feature 18 can be recessed within the shaft 12.
- the guide feature 18 can also have a variety of shapes, however in an exemplary embodiment, the guide feature 18 has a C-shape with two opposed sides that are either straight or curved.
- outer features, including the cross-sectional shape of the shaft itself, can form mating or guiding features.
- a distracting paddle 22 Attached to the distal-most end of the shaft 14 is a distracting paddle 22 that, upon insertion into the cavity, can be rotated to distract adjacent vertebrae to maintain the integrity of the cavity between them.
- paddle 22 has proximal and distal ends 22a, 22b connected by superior and inferior sides 22c, 22d and having a front or guiding face 22e and a back face 22f. While paddle 22 can have a variety of shapes, such as rectangular, circular or oblong, the illustrated paddle 22 is generally rectangular with rounded corners.
- the paddle 22 can also have a variety of sizes to provide a desired level of distraction, so long as it has a width that is less than the diameter of any access portal into the intervertebral space. In an exemplary embodiment, the paddle 22 has a width that is less than about 19mm, and more preferably about 7mm.
- the paddle may also be shaped so as to provide an angle between the inferior and superior sides to match a desired angle of distraction.
- the paddle 22 can have a variety of additional features to assist the surgeon with distraction, which can be used alone or in combination with one another.
- the distal end 22b of the paddle 22 can be arcuate to allow for easier insertion into the intervertebral space 42.
- the superior and/or inferior sides 22c, 22d can have various geometries to enhance the distraction of the intervertebral space 42, such as laterally extending surfaces that provide a larger surface area to contact the vertebrae.
- the back side 22f can also be dome-shaped to aid the surgeon in minimizing damage to the neural tissue surrounding the intervertebral space 42.
- One of superior and inferior sides 22c, 22d can also be provided with a bone engaging element such as one or more teeth to prevent migration of the paddle during distraction.
- guide surface 22e of the paddle 22 can include at least one guide feature such as guide feature 18 extending from the shaft 14 to engage a corresponding element in an implant or implant inserter.
- the implant or implant inserter can be guided by a flat guide surface 22e or by external features of the shaft 14.
- a filler bar 26 can be removably mated to the distractor 12 to provide rigidity and torque strength to the distractor 12 during insertion into the cavity 42 and distraction of the adjacent vertebrae.
- the filler bar 26 has proximal and distal ends 26a, 26b with a shaft 28 extending therebetween.
- the proximal end 26a can have a variety of configurations to assist the surgeon with placement and removal of the filler bar 26 from the distractor 12, however as shown the filler bar 26 has a T-shaped handle 30.
- the proximal end of the filler bar can include a portion of a handle that can mate with a corresponding handle portion on a distractor, such that when mated together, a complete handle is formed.
- the handle portions can mate to one another in a variety of ways, in an exemplary embodiment, the handle portions are mated together by a spring lock mechanism.
- Extending distally from the T-shaped handle 30 is an elongate shaft 28. While the shaft 28 can have a variety of sizes, as shown it has a diameter that is less than the diameter of the distractor. Additionally, the shaft 28 can have a guide feature 32 that corresponds to the guide feature 18 on the distractor 12. That is, the guide feature 32 can be either protruding or recessed, and have a variety of shapes, such as C-shaped with two opposed sides that can be either straight or curved. While the guide feature 32 can be formed throughout the entire length of the shaft 28 or on a partial length thereof, as shown, the groove 32 is formed throughout the entire length of the shaft 28.
- the plate 34 can have any size so long as it is able to fit within the intervertebral space alongside the distractor 12, however in an exemplary embodiment the plate 34 is shaped such that it can nest within the distracting paddle 22, and in particular, within the laterally extending portions of superior and inferior surfaces 22c, 22d. Thus, in an exemplary embodiment, the plate 34 has width that is slightly smaller than the distracting paddle 22 and complementary in shape thereto.
- an implant inserter can be used with the distractor to form a distraction and insertion system.
- the inserter can be similar to inserters known in the art, as well as the inserter 46 shown in FIGS. 7 and 8 .
- the inserter 46 has proximal and distal ends 46a, 46b with a shaft 52 extending therebetween. While the proximal end 46a can have a variety of configurations, in an exemplary embodiment it can have a handle (or a portion thereof) fixedly or removably attached thereto.
- the shaft 52 can have a variety of configurations, the shaft 52 can also optionally include a guide feature 50 that corresponds to the guide feature 18 on the distractor 12, such that the inserter 46 can be mated to the distractor 12.
- the guide feature 50 on the inserter 46 can be either protruding or recessed, and can be, for example, C-shaped with two opposed sides that are either straight or curved.
- the guide feature 50 on the inserter 46 can be formed either throughout the entire length of the shaft 52 or on a partial length of the shaft 52.
- the inserter may simply be guided by a flat surface on the shaft 14 and/or paddle 22 on the distractor 12 or by an external feature of the shaft 14 such as, for example, its superior and/or inferior surfaces.
- an implant 48 Removably mated to the distal most end of the shaft 52 is an implant 48, various embodiments of which will be discussed below.
- the distraction assembly 10 is inserted into the intervertebral space 42 (that is, the space between superior and inferior vertebrae 41, 43) following the excision of disk material.
- the distraction assembly 10 is then rotated approximately 90° such that the paddle 22 is substantially perpendicular to the superior and inferior vertebrae 41, 43, so as to enlarge and/or maintain a desired space within the cavity 42 by the force applied to the vertebrae by superior and inferior surfaces 22c, 22d during rotation.
- an access port such as cannula 51.
- the filler bar 26 can be removed from the distractor 12 to decrease the amount of space that the assembly 10 requires in order to make room for further tools and/or implants as well as to improve the surgeon's ability to visualize the cavity.
- an inserter 46 can then be slidably guided by the distractor 12. Specifically, the surgeon slidably mates the guide features 18, 32, if any, on the distractor 12 and the inserter 46 to one another, and the inserter 46 is slid distally along the distractor 12 into the intervertebral space 42. Once the inserter 46 is placed within the cavity 42, the implant 48 can then be maneuvered so as to achieve the desired orientation.
- the distractor assembly disclosed herein can also optionally include a measurement system (not shown).
- the measurement system can be any indication that allows a surgeon to determine the depth of placement of the distractor, a trial implant or the implant. In an exemplary embodiment, however, the measurement system is formed along the entire length of the shafts of the distractor, filler bar, and/or inserter, or only on a portion thereof.
- the distractor can included at least one colored band so as to color code for the height of the distraction paddle that the distractor can be matched to a similarly color coded trial implant and/or implant so that a surgeon can readily ensure that all are of the same height.
- FIGS. 9 to 43 illustrate distractors having features that assist a surgeon in inserting an implant into an intervertebral space at a desired angle.
- the distractors described below can have features and methods of use similar to those of distractor 12 discussed above.
- FIGS. 9 to 11 illustrate a distractor 112 that includes a paddle 122 having an angled distal end 122b, and thus providing an angled guide surface 122c.
- an implant is designed for placement at a certain angle of trajectory between the adjacent vertebrae and/or a surgeon chooses a particular angle of placement in order to achieve desired fusion characteristics.
- Minimally invasive approaches to the disk space provide well documented advantages, however, establishing a minimally invasive access portal while sparing sensitive nerve tissues from contact and possible damage requires approach angles to the disk space that may not match the desired angle of placement of the implant. For example, a typical TLIF approach may take a 35° angle (plus or minus depending on the anatomy of a particular patient) while the desired angle for placement of the implant may be 45°.
- Providing an angled distal end 122b on the distractor paddle 122 allows the surgeon to carefully guide the implant during insertion to the desired angle with a reduced chance of contacting sensitive nerve tissue. While the distal end 122b of the paddle 122 can have a variety of angles as desired by the surgeon, in the illustrated embodiment, the distal end 122b of the paddle 122 has an angle of about 20°.
- Paddle 122 can further include opposed overhanging tabs 123a, 123b and a curved distal end 122b.
- the overhanging tabs 123a, 123b can be any configuration that can serve as a guide for the implant 148, however, as shown, the overhanging tabs 123a, 123b are rectangular and extend horizontally from the guide surface 122c of the paddle 122.
- the overhanging tabs 123a, 123b of the paddle 122 can slidingly engage the outer edge surfaces of the implant 148. Once engaged, the implant 148 is guided along the length of the paddle 122. As the implant 148 approaches the distal end 122b of the paddle 122, the angled distal end 122b urges the implant 148 into the desired orientation within the intervertebral space 142.
- FIGS. 12 to 13 illustrate an angled distractor 212 that includes a shape memory metal shim 211. While the metal shim 211 can have any configuration to allow for the angled insertion of an implant 248, as shown the memory metal shim 211 is provided as a separate element from the distractor 212 that is placed along the side of the shaft 214 and paddle 222 of the distractor 212. Shim 211 can be held flat to the shaft 214 and/or paddle 222 of the distractor by one or more guide elements 213.
- extension of the shim 211 distally along the paddle 222 causes the shim to return to a curved shape.
- the angle of curvature of the shape memory metal shim 211 can be any angle that allows a surgeon to implant an spinal prosthesis into an intervertebral space 242, however in an exemplary embodiment, the curve of the shim 211 has an angle of about 20°.
- An implant 248 is then inserted into the intervertebral space 142 and, upon contact with the shim 211, is directed towards the desired placement angle within the intervertebral space 242.
- the shim 211 can also be retracted/straightened so that retraction of the distractor 212 does not displace the implant and so that retraction of the distractor does not disturb sensitive tissue.
- the shim 211 can be made of any biocompatible material known to have shape memory or superelastic properties such as, for example, the NITINOL (an acronym for Nickel Titanium Naval Ordnance Laboratory) family of intermetallic materials, which contain a nearly equal mixture of nickel (55 wt. %) and titanium.
- NITINOL an acronym for Nickel Titanium Naval Ordnance Laboratory
- the shim 211 conform to the shape of the distractor 212 during insertion and then retain its curved shape once it is placed within the intervertebral space 242 allows for a reduced profile for insertion and retraction through a minimally invasive surgical access point.
- FIGS. 14 to 17 illustrate a distractor 312 that includes a paddle 322 having a shape memory metal shim 311 similar to metal shim 211 (described above), as well as extension shoulders 333a, 333b. While the extension shoulders 333a, 333b can have a variety of configurations, in an exemplary embodiment, they are slidably located on the paddle 322 and expendable from the superior and inferior sides thereof. However, in an alternate embodiment (not shown), a single extension shoulder can be formed on the paddle.
- extension shoulders 333a, 323b can increase the height of the paddle 322 by any amount as desired by the surgeon to achieve and maintain a desired level of distraction of intervertebral space 342, in an exemplary embodiment, the paddle has a height of approximately 7mm and extension shoulders 333a, 333b increase the diameter of the paddle 322 by an amount up to approximately 4mm.
- the memory metal shim 311 extends beyond the distal end 322b of the paddle 322, and retains its curved shape, such that the surgeon can place the implant 348 into the cavity 342 at a desired angle.
- FIGS. 18 to 20 illustrate a distractor 412 having an internal shim 409, as well as extension shoulders 433a, 433b.
- the internal shim 409 can be formed in a variety of ways, as shown the internal shim is 409 is formed within a sheath 407 surrounding the shaft 414 of the distractor 412.
- the internal shim 409 can also include an expansion mechanism such that, in use, and similar to the memory metal shim 211 discussed above, the internal shim 409 drives the extension shoulders 433a, 433b upward and downward, respectively, as the surgeon desires.
- the expanding shoulders 533a, 533b of a distractor 512 can be driven by an internal shim 509 having a linkage assembly 505.
- the linkage assembly 505 can be formed in a variety of ways, as shown the linkage assembly 505 is also formed within a sheath 507 surrounding the shaft 514 of the distractor 512.
- the internal shim 509 can drive the linkage assembly 505 to control the height of the extension shoulders 533a, 533b as desired.
- FIGS. 24 to 26 illustrate a distractor 612 having an inserter arm 660 for positioning the distractor.
- Distractor 612 can include an internal shim 609 and extension shoulders 633a, 633b, similar to those as discussed above.
- the inserter arm 660 can be removed after placement of the distractor 612, and a cable 662 is left behind extending distally from the distractor 612.
- the shim 609 drives the extension shoulders 633a, 633b to set a height adjustment, similar to that as described above with respect to extension shoulders 333a, 333b.
- the inserter arm 660 can be slidably removed from the cable 662, resulting in the cable 662 extending out of the intervertebral space 642.
- the cable 662 can then either be removed or used as a guide for other surgical instruments.
- the shim 609 can also optionally include a sliding support 613 that can be slid along the shaft 614 of the distractor 612 to lock the extension shoulders 633a, 633b in place, and help secure the distracted height of the cavity 642.
- the cable 662 can be made from a variety of materials depending upon its desired use by the surgeon. For example, if the surgeon desires the cable to be used as a guide for future instruments or procedures, the cable can be made of any desirable surgical material of sufficient guide strength.
- FIGS. 27 to 36 illustrate implant inserters having features that assist a surgeon in inserting an implant into an intervertebral space at a desired angle.
- the inserters of the embodiments described below can have features and can be used in a manner similar to that of inserter 46, discussed above.
- the shafts of the inserters in the embodiments described below may or may not include a guide feature for slidably engaging with another surgical instrument.
- FIGS. 27 to 29 illustrate an inserter 746 that includes a hinge pivot joint 770 and a linkage mechanism 772. While the hinge pivot joint 770 and the linkage mechanism 772 can have a variety of configurations to drive the implant 748 to desired angulations, in one embodiment, the hinge pivot joint 770 and a linkage mechanism 772 are formed at the distal end 746b of the inserter 746, and located external to the shaft 752 thereof. Alternatively, the hinge pivot joint 770 and the linkage mechanism 772 can be formed within a pathway (not shown) contained within the shaft 752 of the inserter 746.
- the inserter 746 can also include a variety of means by which the surgeon can control the hinge pivot joint 770 and the linkage assembly 772, such as, for example, a spring bias built into or placed on the pivot joint, and control the movement in response to the bias by proximal or distal movement of the linkage assembly.
- the surgeon can maneuver the linkage mechanism such that the hinge pivot joint 770 and a linkage mechanism 772 cooperate to place the implant 748 at a desired angle.
- FIGS. 30 to 33 show another inserter 846 that includes mating impaction arms 878a, 878b to rotate the implant 848 to the desired orientation. While the mating impaction arms 878a, 878b can rotate the implant 848 in a variety of ways, as shown, the mating impaction arms 878a, 878b include a mating face 879 that allows high impaction forces on the implant 848 by maintaining a high surface area of contact. Handle or knob 883 is rotated to drive the impaction arms relative to each other so as to rotate the implant, and the position of the knob can indicate the angle to which the implant is rotated as can be seen in the differential angulations illustrated by comparing FIGS. 30 and 31 .
- the mating face 879 can have any configuration, but preferably allows for a high surface area contact with the implant 848, however in an exemplary embodiment the mating face 879 includes an adjustable driving mechanism having a movable protrusion 881 mated to the cavity of an implant 848.
- FIG. 32 illustrates an up close view of the translating impaction arms described above for an inserter that allows for implant rotation during insertion.
- the implant 848 includes an internal cavity 885 in which a inserter driver 881 mates while allowing the implant to rotate.
- the implant 848 is loaded by inserting the driver 881 into the implant cavity 885 and rotating the driver 90 degrees as illustrated in FIG. 34 (loading position) and FIG. 33 (insertion position).
- the implant 848 can be removed from the inserter by rotating the implant 90 degrees, in the reverse of the loading step for example.
- FIGS. 34 to 35 illustrates another inserter 946 that allows cable rotation of implant 948 with respect to vertebra 941 by a cable 962 that is linked to the implant 948.
- Inserter shaft 952 permits rotation of the implant in a hinge-like manner when the cable 962 is operated by the surgeon to drive the rotation.
- the cable 962 must be disengaged from at least one of the implant 948 (in which case the cable 962 is removed with the shaft 952) or the shaft 952 (in which case the cable 962 is left behind with the implant 948). If the cable 962 is left behind, it can be formed, for example, from a bioabsorbable material.
- FIG. 36 illustrates an exemplary implant driver 1346 that can be used with inserter 946 to permit rotation of the implant 1348.
- the implant 1348 includes an external boss feature 1387 that is held between two inserter tabs 1388a, 1388b.
- the inserter tabs 1388a, 1388b can have a variety of configurations, however in an exemplary embodiment, they include an inserter tab movement mechanism that allows a surgeon to adjust the angulation of the implant 1348, for example by using cable 962 from the embodiment of FIGS. 34 and 35 .
- external boss feature 1387 and tabs 1388a, 1388b are the inverse of cavity 885 and inserter driver 881 from the embodiment of FIGS. 32 and 33 . Both configurations can allow angulation of the implant, but by contact with external and internal surfaces of the implant respectively.
- the inserter can have a controlled insertion feature to allow incremental insertion and placement of an implant 1048, such as, for example a ratchet gun.
- an implant 1048 such as, for example a ratchet gun.
- the ratchet gun inserter 1080 can include a flexible sheath 1081 to protect the neural tissue from injury during insertion into the intervertebral space 1042 of implant 1048 through minimally invasive access port 1082.
- Ratchet gun inserter 1080 can further include a flexible inserter connection 1085, such as metal laser cut tubing or helical springs, can be used to allow for implant rotation as described in other embodiments.
- FIGS. 38 and 39 show a ratchet gun 1180 that includes distraction paddles 1184a, 1184b. While the distraction paddles 1184a, 1184b can have a variety of configurations known in the art, in an exemplary embodiment, they extend from the distal most end of the ratchet gun and are shaped and sized such that they fit against the inner surfaces of the superior and inferior vertebrae 1141, 1143. As this embodiment includes paddle distractors, inserter 1180 is not intended to be guided by a paddle distractor as with embodiments described above.
- the surgeon inserts the ratchet gun inserter 1180 into the intervertebral space 1142 and squeezes the handle of the gun (likely repeatedly) so that implant 1148 slides between distraction paddles 1184a, 1184b and extends the paddles away from each other to distract the intervertebral space 1142.
- a ratchet gun inserter 1280 can include a rotating inserter 1247 that can have any configuration as described herein (above in FIGS. 27 to 36 ).
- the ratchet gun 1280 can include a memory metal shim 1211, such as that described in FIGS. 12 and 13 above to allow insertion of an implant at a desired angulation.
- a variety of implants can be used with the instruments disclosed above, such as, for example, the implants disclosed in U.S. Patent No. 4,743,256 to Brantigan , U.S. Patent No. 4,834,757 to Brantigan , U.S. Patent No. 4,878,915 to Brantigan , U.S. Patent No. 5,192,327 to Brantigan , U.S. Patent No. 5,425,772 to Brantigan , U.S. Patent No. 5,716,415 to Steffee , U.S. Patent No. 5,984,922 to Mckay , U.S. Patent No. 6,245,108 to Biscup , as well as the implants disclosed in FIGS. 44 to 46 .
- the implant 1448 has opposed front and back ends 1448 a, 1448b and parallel side surfaces 1448c, 1448d.
- Upper and lower surfaces 1448e, 1448f that engage the adjacent vertebrae extend between the side surfaces 1448c, 1448d, and such a cavity 1493 is formed within the center of the implant 1448.
- the back end 1448b of the implant 1448 can have a profile and features to mate with an inserter instrument such as are known in the art or as described above. Additionally, at least one slot 1490 for vascularization can be formed in at least one of the parallel side surfaces 1448c, 1448d and/or the upper and lower surfaces 1448e, 1448f. While the slots 1490 can have a variety of shapes, e.g., circular, ovular, spherical, as shown the slot is ovular.
- At least one of the parallel side surfaces 1448c, 1448d and/or the upper and lower surfaces 1448e, 1448f has a plurality of pyramid-shaped teeth 1492 formed thereon and extending outward to contact the superior and inferior vertebral surfaces 41, 43 and to resist retropulsion of the implant during or after insertion.
- the front end 1448a of the implant 1448 can have a geometry that allows for entry into the disk past neural elements and for easier manipulation in the disk space. While this geometry can have a variety of forms, in an exemplary embodiment, it is a bullet-shaped profile, with a bulleted front profile in at least one, but preferably two planes. One skilled in the art will appreciate that the implant having a bullet formed in two planes is able to more effectively distract the vertebrae and neural tissue. ,
- the interior of the parallel side surfaces 1448c, 1448d and/or the upper and lower surfaces 1448e, 1448f can include a plurality of ridges 1491 formed thereon for the maximum retention of the bone graft material within the cavity 1493.
- the ridges 1491 can have a variety of shapes, in an exemplary embodiment the ridges 1491 can be slots that extend vertically along the interior surface of the parallel side surfaces 1448c, 1448d and/or the upper and lower surfaces 1448e, 1448f.
- the ridges 1491 can be slots that horizontally extend along the inner surface of the parallel side surfaces 1448c, 1448d and/or the upper and lower surfaces 1448e, 1448f.
- the inner surfaces of the parallel side surfaces 1448c, 1448d and/or the upper and lower surfaces 1448e, 1448f can include both vertically and horizontally extending ridges 1491.
- upper surface 1448e of the implant 1448 can have a dome structure formed thereon. While the dome can have a variety of configurations, in an exemplary embodiment the dome is angled such that it corresponds to the shape of the superior and inferior vertebrae at a desired angle of rotation. One skilled in the art will appreciate that this implant allows for insertion at an angle that is approximately 35° off of the midline of the vertebrae.
- the materials used for forming the implants disclosed herein can vary.
- One preferred material from which the implant can be made is a carbon fiber reinforced polymer.
- Other materials from which the implants can be made include metals, metal alloys, biologically compatible polymers, allograft bone, and combinations of these materials.
- suitable polymers include polyether sulfone, polycarbonate, and bioabsorbable polymers, and examples of suitable composites include carbon fiber reinforced polymers.
- suitable metals include titanium, stainless steel, tantalum, cobalt chromium, aluminum, and combinations thereof.
- a graft material funnel 2 can also be used with the distractor assembly disclosed herein.
- the graft material funnel 2 has proximal and distal ends 2a, 2b connected by a shaft 6.
- the proximal end 2a can have a variety of features known in the art to contain bone graft material to be siphoned into the implant.
- the shaft 6 can have a variety of configurations, such as elongate or curved, as shown it is curved.
- the curved shape of the shaft allows rotation to implant graft material to a desired location.
- the shaft 6 can be made from a variety of materials, in an exemplary embodiment, the shaft 6 is made from a material that allows for the shaft diameter to have some flexibility, such that the graft material can be introduced into the funnel 2 without clogging.
- the instruments described herein can be made from any suitable surgical grade material, including surgical grade stainless steel, titanium, aluminum, tantalum, cobalt chromium, plastics, and combinations and copolymers thereof.
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- Electrotherapy Devices (AREA)
- Surgical Instruments (AREA)
Claims (19)
- Chirurgisches Instrumentensystem, das aufweist:einen Distraktor, der einen Schaft (14) und ein Paddel (22) umfasst, wobei sich das Paddel an einem distalen Ende des Schaftes befindet; dadurch gekennzeichnet, dassein Füllstab (26) so geformt ist, dass er den Schaft und das Paddel des Distraktors lösbar greift;wobei, wenn der Füllstab im Eingriff mit dem Distraktor ist, der Füllstab für Steifigkeit und Drehmomentfestigkeit sorgt, so dass der Distraktor zwischen benachbarte Wirbel in einer ersten Ausrichtung eingesetzt und gedreht werden kann, um die benachbarten Wirbel zu spreizen.
- System nach Anspruch 1, bei dem das Paddel des Distraktors eine erste Höhenabmessung umfasst, wenn es in eine Einsetzausrichtung gebracht ist, und eine zweite Höhenabmessung, wenn es ungefähr 90 Grad zu einer Spreizausrichtung gedreht ist, wobei die zweite Höhenabmessung größer ist als die erste Höhenabmessung, wobei das Paddel unten liegende und oben liegende Flächen (22c, d) zum Berühren benachbarter Wirbel in der Spreizausrichtung hat.
- System nach Anspruch 2, bei dem sich der Füllstab im Wesentlichen entlang wenigstens einer Seite des Schaftes und des Paddels erstreckt.
- System nach Anspruch 3, bei dem der Füllstab so bemessen ist, dass er sich nicht über die oben liegende und unten liegende Fläche des Paddels hinaus erstreckt.
- System nach Anspruch 3, bei dem der Füllstab verschieblich entlang einer Längsachse des Distraktors in den Distraktor einzuführen und aus ihm heraus zu bewegen ist.
- System nach Anspruch 2, wobei wenigstens eine, die unten liegende oder die oben liegende Fläche des Paddels, eine Einrichtung zum Verhindern des Wanderns des Distraktors während des Spreizens umfasst.
- System nach Anspruch 6, bei dem die Einrichtung zum Verhindern des Wanderns ein Knocheneingriffselement umfasst.
- System nach Anspruch 7, bei dem das am Knochen angreifende Element wenigstens einen Zahn umfasst.
- System nach Anspruch 6, bei dem die Einrichtung zum Verhindern des Wanderns wenigstens eine Verlängerungsschulter umfasst, die so betrieben werden kann, dass sie sich über wenigstens eine, die unten liegende oder die oben liegende Fläche hinaus erstreckt, um so die zweite Höhenabmessung zu vergrößern.
- System nach Anspruch 2, bei dem das Paddel und der Schaft des Distraktors eine Führungsfläche zum Führen des Anordnens eines Implantates darstellen, wenn der Distraktor in der Spreizausrichtung ist, und das Paddel des Distraktors weiter ein gewinkeltes Führungsmerkmal aufweist, das so ausgelegt ist, dass sie ein Implantat durch eine Teildrehung in einen gewünschten Winkel führt.
- System nach Anspruch 10, bei dem das gewinkelte Führungsmerkmal eine gewinkelte Fläche einstückig mit einem distalen Bereich des Paddels umfasst.
- System nach Anspruch 10, bei dem das gewinkelte Führungsmerkmal auf einer bewegbaren Unterlage vorgesehen ist, die so betreibbar ist, dass sie sich von der Führungsfläche erstreckt, um ein Implantat durch eine Teildrehung zu führen.
- System nach Anspruch 12, bei dem die bewegbare Unterlage zurückzuziehen ist.
- System nach Anspruch 10, bei dem das gewinkelte Führungsmerkmal aus einem Material mit Formgedächtnis gebildet ist.
- System nach Anspruch 10, weiter mit einer Einführhilfe für ein Implantat mit einem gewinkelten distalen Ende, wobei der Winkel ungefähr dem Winkel entspricht, der auf dem gewinkelten Führungsmerkmal vorgesehen ist.
- System nach Anspruch 10, weiter mit einer Einführhilfe für ein Implantat mit einem gelenkigen Implantathalter, der so betreibbar ist, dass er ein Implantat in einen gewünschten Winkel dreht.
- System nach Anspruch 2, das weiter einen minimalinvasiven Zugangsport aufweist, durch den der geeignet bemessene Distraktor gebracht werden kann.
- System nach Anspruch 2, weiter mit einem Führungsmerkmal, das sich entlang dem Schaft und dem Paddel erstreckt, wobei das Führungsmerkmal so ausgelegt ist, dass es wenigstens einem aus einem Implantat und einer Einführhilfe für ein Implantat entspricht, um ein Einführen eines Implantates entlang dem Distraktor zu leiten.
- System nach Anspruch 2, das weiter wenigstens einen überhängenden Ansatz aufweist, der auf wenigstens einer, der unten liegenden und der oben liegenden Fläche, vorgesehen ist.
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US54303004P | 2004-02-09 | 2004-02-09 | |
PCT/US2005/004136 WO2005077288A1 (en) | 2004-02-09 | 2005-02-09 | Systems and methods for spinal surgery |
Publications (3)
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EP1713408A1 EP1713408A1 (de) | 2006-10-25 |
EP1713408A4 EP1713408A4 (de) | 2009-02-18 |
EP1713408B1 true EP1713408B1 (de) | 2010-09-15 |
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EP05713229A Active EP1713408B1 (de) | 2004-02-09 | 2005-02-09 | Systeme für die wirbelsäulen-chirurgie |
Country Status (9)
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US (3) | US8016829B2 (de) |
EP (1) | EP1713408B1 (de) |
JP (1) | JP2007521886A (de) |
AT (1) | ATE481035T1 (de) |
AU (2) | AU2005212352B2 (de) |
CA (2) | CA2793237C (de) |
DE (1) | DE602005023583D1 (de) |
ES (1) | ES2350584T3 (de) |
WO (1) | WO2005077288A1 (de) |
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-
2005
- 2005-02-09 CA CA 2793237 patent/CA2793237C/en not_active Expired - Fee Related
- 2005-02-09 CA CA2555876A patent/CA2555876C/en not_active Expired - Fee Related
- 2005-02-09 EP EP05713229A patent/EP1713408B1/de active Active
- 2005-02-09 US US10/579,146 patent/US8016829B2/en active Active
- 2005-02-09 WO PCT/US2005/004136 patent/WO2005077288A1/en active Application Filing
- 2005-02-09 JP JP2006552361A patent/JP2007521886A/ja active Pending
- 2005-02-09 DE DE602005023583T patent/DE602005023583D1/de active Active
- 2005-02-09 AT AT05713229T patent/ATE481035T1/de not_active IP Right Cessation
- 2005-02-09 AU AU2005212352A patent/AU2005212352B2/en not_active Ceased
- 2005-02-09 ES ES05713229T patent/ES2350584T3/es active Active
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11931053B2 (en) | 2022-08-04 | 2024-03-19 | PTL Opco, LLC | Single-use joint decorticator apparatus |
Also Published As
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EP1713408A1 (de) | 2006-10-25 |
CA2793237C (en) | 2015-04-21 |
CA2555876A1 (en) | 2005-08-25 |
JP2007521886A (ja) | 2007-08-09 |
US9180024B2 (en) | 2015-11-10 |
US20110276139A1 (en) | 2011-11-10 |
ATE481035T1 (de) | 2010-10-15 |
US20070276406A1 (en) | 2007-11-29 |
AU2011200592B2 (en) | 2012-02-23 |
US10398425B2 (en) | 2019-09-03 |
AU2005212352B2 (en) | 2010-11-18 |
DE602005023583D1 (de) | 2010-10-28 |
WO2005077288A1 (en) | 2005-08-25 |
US8016829B2 (en) | 2011-09-13 |
CA2793237A1 (en) | 2005-08-25 |
EP1713408A4 (de) | 2009-02-18 |
ES2350584T3 (es) | 2011-01-25 |
AU2011200592A1 (en) | 2011-03-03 |
AU2005212352A1 (en) | 2005-08-25 |
CA2555876C (en) | 2012-12-11 |
US20160030029A1 (en) | 2016-02-04 |
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